Elastic Band-Progressive Resistance Training (EB-PRT) for Sarcopenia Among Heart Failure Patients

NCT06161402 | Recruiting

• 1 other identifier: EB-PRT
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure (HF) is a complicated clinical syndrome caused by structural and/or functional cardiac abnormalities that result in ineffective myocardial pumping. HF management has placed more emphasis on improving the prognostic factors which determine these poor clinical outcomes. More recently, the prognostic role of sarcopenia in HF has received particular attention. Defined as progressive and generalized decline in skeletal muscle mass, strength and physical performance due to aging, sarcopenia is definitely a common comorbid of HF which follows an age-specific disease epidemiology. Given muscle disuse is the most preventable and reversible factor of sarcopenia, more evidence points to the therapeutic value of resistance training (RT) for this debilitating condition. Nevertheless, the therapeutic effects of RT on improving sarcopenia and thereby the disease prognosis among HF patients is yet to be evaluated. Therefore, the sequential mixed method study including a pilot RCT will be conducted to evaluate the preliminary effect of a 14-week elastic band-progressive resistance training (EB-PRT) and a subsequent qualitative study to explore the subjects' engagement experience. The outcomes cover the whole set of defining characteristics including muscle mass, muscle strength and functional performance and the clinical outcomes which reflect HF disease severity and patient-reported HRQL.

Conditions

Heart Failure

Keywords

Heart Failure; Sarcopenia; Resistant Training

Outcome Measures

Primary Outcomes (3)

• Appendicular skeletal muscular index (ASMI)

  ASMI will be measured by the bioimpedance analysis (BIA) method. Reduced muscle mass is defined if ASMI \<7.0kg/m2 for male, ASMI \<5.7kg/m2 for female.

  Changes from baseline to 14 weeks (1st post-test) and 26 weeks (2nd post-test).

• Handgrip strength

  Handgrip strength will be measured by a hydraulic hand dynamometer from dominant hand, taking the highest value among 3 measurements. Low muscle strength is defined if male \<28kg, and femal \<18kg.

  Changes from baseline to 14 weeks (1st post-test) and 26 weeks (2nd post-test).

• Physical function

  Physical function will be measured by the Short Physical Performance Battery (SPPB), which combines balance test, gait velocity and chair stand. SPPB score ranges from 0-12, higher score better physical performance. Low physical function is defined by SPPB score ≤9.

  Changes from baseline to 14 weeks (1st post-test) and 26 weeks (2nd post-test).

Secondary Outcomes (2)

• Symptom burden

  Changes from baseline to 14 weeks (1st post-test) and 26 weeks (2nd post-test).

• Health-Related Quality of Life (HRQL)

  Changes from baseline to 14 weeks (1st post-test) and 26 weeks (2nd post-test).

Study Arms (2)

EB-PRT

EXPERIMENTAL

EB-PRT will implemented during week 1-14. A purposive sample of 12 participants invited for qualitative interview during 21st -22nd week. There are 2 post-test evaluations at 14th week and 26th week. After the second evaluation at week 26, the group will receive usual care with routine follow-up.

Behavioral: Elastic band-based progressive resistance training (EB-PRT)

Usual care

NO INTERVENTION

The control group will receive usual care including the medical care offered by the specialist out-patient clinic during 1-26 week. There are 2 post-test evaluations at 14th week and 26th week. From week 27 to week 40, this wait-list control group will receive the same EB-PRT as the intervention group.

Interventions

Elastic band-based progressive resistance training (EB-PRT) BEHAVIORAL

EB-PRT will be implemented during week 1-14. The EB-PRT comprises a 4-week training phase, 6-week consolidation phase and a 4-week maintenance phase.

EB-PRT

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 50;
• has a confirmed clinical diagnosis of HF in the electronic health record for at least 6 months to ensure adequate disease exposure;
• meeting the Asian Working Group of Sarcopenia's criteria2 \[grip strength measured by dynamometer (Male: \<28kg; Female: \<18kg); low physical function (defined by Short Physical Performance Battery score ≤9) and reduced muscle mass by bioimpedance analysis (Inbody Technology 270; Male: appendicular skeletal muscular index (ASMI) \<7.0kg/m2, Female: \<5.7kg/m2)\];
• has stable HF and do not have any acute respiratory and musculo-skeletal condition which contradict them from practising exercise;
• no regular resistance training for the previous 6 months.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Hospital Authority, Hong Kong: collaborator

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Heart Failure; Sarcopenia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Doris Sau Fung YU, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Doris Sau Fung YU, PhD

CONTACT

852 3817 6319; dyu1@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: December 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

HK (1)